Amoxicillin Mylan Pharma: detailed information

Package leaflet: Information for the user

Amoxicillina Mylan Pharma 1000 mg dispersible tablets

Amoxicillin
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Amoxicillina Mylan Pharma is and what it is used for
What you need to know before taking Amoxicillina Mylan Pharma
How to take Amoxicillina Mylan Pharma
Possible side effects
How to store Amoxicillina Mylan Pharma
Contents of the pack and other information

1. What Amoxicillina Mylan Pharma is and what it is used for

What Amoxicillina Mylan Pharma is
Amoxicillina Mylan Pharma is an antibiotic. Its active substance, called amoxicillin,
belongs to a group of medicines known as "penicillins".
What Amoxicillina Mylan Pharma is used for
Amoxicillina Mylan Pharma is used to treat bacterial infections in various parts of the
body. Amoxicillina Mylan Pharma may also be used in combination with other medicines
for the treatment of gastric ulcers.

2. What you need to know before taking Amoxicillina Mylan Pharma

Do not take Amoxicillina Mylan Pharma:

if you are allergic to amoxicillin, penicillin, or any of the other ingredients of this medicine (listed in section 6).
if you have previously had an allergic reaction to any antibiotic. This includes skin rash or development of swelling of the face or throat.

Do not take Amoxicillina Mylan Pharma if any of the above situations apply to you. If you have any doubts, consult your doctor or pharmacist before taking Amoxicillina Mylan Pharma.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Amoxicillina Mylan Pharma if:

you have glandular fever (fever, sore throat, swollen glands, and extreme tiredness)
you have kidney problems
you do not urinate regularly.

If you are unsure whether any of the above points apply to you, consult your doctor or pharmacist before taking Amoxicillina Mylan Pharma.
Blood and urine tests
If you are undergoing:

urine tests (for glucose) or blood tests for liver function
tests for oestriol (used during pregnancy to monitor normal fetal development), inform your doctor or pharmacist that you are taking Amoxicillina Mylan Pharma, as this medicine may alter the results of these tests.

Other medicines and Amoxicillina Mylan Pharma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you are taking allopurinol (a medicine used to treat gout) together with Amoxicillina Mylan Pharma, you may be more likely to develop an allergic skin reaction.
If you are taking probenecid (used to treat gout), this may reduce the excretion of amoxicillin and is not recommended. Your doctor may decide to adjust the dose of Amoxicillina Mylan Pharma.
If you are taking medicines to prevent blood clots (e.g. warfarin), you may need additional blood tests.
If you are taking other antibiotics (e.g. tetracyclines), Amoxicillina Mylan Pharma may be less effective.
If you are taking methotrexate (used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate, potentially increasing its side effects.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Amoxicillina Mylan Pharma may cause side effects such as allergic reactions, dizziness, and seizures, which may impair your ability to drive.
Do not drive or operate machinery if you do not feel well.
Amoxicillina Mylan Pharma contains 20 mg of aspartame in each 1000 mg tablet
Aspartame (E951) is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to build up because the body cannot process it properly.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.
Amoxicillina Mylan Pharma contains maltodextrin, a source of glucose. If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Amoxicillin Mylan Pharma

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

The tablets can be used in two ways: disperse the tablet in a glass of water and then drink it, or take the tablet directly with water. The tablets may be broken to facilitate swallowing.
Take the doses at regular intervals throughout the day, at least 4 hours apart.

Usual dose:
Children weighing less than 40 kg
All doses are calculated according to the child's body weight in kilograms.

Your doctor will tell you how much Amoxicillin Mylan Pharma to give your child.
The usual dose ranges from 40 mg to 90 mg per kilogram of body weight per day, given in two or three divided doses.
The maximum dose is 100 mg per kilogram of body weight per day.

Adults, elderly patients, and children weighing 40 kg or more
The usual dose of Amoxicillin Mylan Pharma is 250–500 mg three times a day or 750 mg–1 g every 12 hours, depending on the severity and type of infection.

Severe infections: 750 mg to 1 g three times a day.
Urinary tract infections: 3 g twice a day for one day.
Lyme disease (an infection caused by a parasite called a tick): isolated erythema migrans (early stage – circular red or pink rash): 4 g per day; systemic manifestations (late stage – more severe symptoms or when the disease spreads to other parts of the body): up to 6 g per day.
Gastric ulcers: one dose of 750 mg or one dose of 1 g twice daily for 7 days, together with other antibiotics and medicines for treating gastric ulcers.
Prevention of heart infections during surgical procedures: the dose will vary depending on the type of surgery. Other medicines may also be administered at the same time. Your doctor, pharmacist, or nurse will provide more detailed information.
The maximum recommended dose is 6 g per day.

Renal impairment
If you have kidney problems, your dose may be lower than usual.
If you take more Amoxicillin Mylan Pharma than you should
If you take an excessive amount of Amoxicillin Mylan Pharma, symptoms such as gastrointestinal disturbances (nausea, vomiting, or diarrhoea) or presence of crystals in the urine, possibly causing cloudy urine or difficulty urinating, may occur. Contact your doctor as soon as possible, and bring the medicine with you to show it.

If you forget to take Amoxicillin Mylan Pharma

If you forget a dose, take it as soon as you remember.
Do not take the next dose too early; wait approximately 4 hours before taking the next dose.
Do not take a double dose to make up for a missed dose.

How long should you take Amoxicillin Mylan Pharma?

Continue taking Amoxicillin Mylan Pharma for the duration prescribed by your doctor, even if you feel better. It is necessary to take all prescribed doses to fully treat the infection. The infection may return if some bacteria survive.
If, after completing the treatment, you still do not feel well, contact your doctor again.

Prolonged use of Amoxicillin Mylan Pharma may lead to the development of candidiasis (a yeast infection affecting moist areas of the body, causing irritation, itching, and white discharge). If this occurs, consult your doctor.
If you take Amoxicillin Mylan Pharma for a long time, your doctor may carry out additional tests to monitor your kidneys, liver, and blood.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Amoxicillina Mylan Pharma and consult a doctor immediately if you experience any
of the following serious side effects, as urgent medical treatment may be required:
The following side effects are very rare (may affect up to 1 in 10,000 people):

allergic reactions, accompanied by signs such as itching or skin rash, swelling of the face, lips, tongue or body, or difficulty breathing. These effects can be severe and, in some cases, have been fatal
skin rash or appearance of small, round, flat, red spots under the skin surface, or skin bruising. This is due to inflammation of blood vessel walls caused by an allergic reaction. It may be accompanied by joint pain (arthritis) and kidney problems
a delayed allergic reaction, usually occurring 7–12 days after taking Amoxicillina Mylan Pharma, accompanied by signs such as skin rash, fever, joint pain, and swollen lymph nodes, particularly those under the arm
a skin reaction called "erythema multiforme", with itchy, reddish-purple patches on the skin, particularly on the palms of the hands or soles of the feet, areas of skin swelling similar to hives, or painful areas on the surface of the mouth, eyes, and genitals. This may be accompanied by fever and a feeling of extreme tiredness
other severe skin reactions may include changes in skin colour, formation of lumps under the skin, appearance of blisters, pustules, peeling, redness, pain, itching, and flaking, and may be associated with fever, headache, and widespread pain
flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms)
fever, chills, sore throat, or other signs of infection, or a tendency to bruise easily. These may be signs of a blood cell disorder
inflammation of the large intestine (colon) with diarrhoea (sometimes containing blood), pain, and fever
serious side effects affecting the liver may occur, observed mainly in patients treated for long periods, in men, and in elderly people. Inform your doctor urgently if you notice: severe diarrhoea with bleeding or blisters, skin redness or bruising, dark urine, pale stools, or yellowing of the skin or the white part of the eye (jaundice). See also the entry on anaemia below as a possible cause of jaundice.

These effects may occur during treatment with the medicine or even several weeks later.
The following side effects have unknown frequency:

Jarisch-Herxheimer reaction, which may occur during treatment of Lyme disease with Amoxicillina Mylan Pharma, causing fever, chills, headache, muscle pain, and skin rash
chest pain occurring in the context of allergic reactions, which may be a symptom of allergic-triggered heart attack (Kounis syndrome)
red skin rash commonly appearing on both sides of the buttocks, upper inner thighs, armpits, and neck (symmetrical drug-related intertriginous flexural exanthema (SDRIFE))
drug-induced enterocolitis syndrome (DIES) has been reported mainly in children treated with amoxicillin. It is a type of allergic reaction with the main symptom being repeated vomiting (1–4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.

If any of the above-listed effects occur, stop treatment with the medicine and consult a doctor
immediately.
Sometimes less severe skin reactions may occur, such as:

a slightly itchy rash (round pink-red patches), localized swelling similar to hives on the forearms, legs, palms of the hands, hands or feet. This is an uncommon effect (may affect up to 1 in 100 people).

If any of these side effects occur, consult your doctor, as treatment with Amoxicillina Mylan Pharma
may need to be discontinued.
Other possible side effects include:
Common (may affect up to 1 in 10 people):

skin rash
nausea
diarrhoea

Uncommon (may affect up to 1 in 100 people):

vomiting

Very rare (may affect up to 1 in 10,000 people):

candidiasis (yeast infection of the vagina, mouth, or skin folds); your doctor or pharmacist can provide appropriate treatment for candidiasis
kidney problems
seizures, observed in patients receiving high doses or with kidney problems
dizziness
hyperactivity
presence of crystals in the urine leading to acute kidney injury, possibly causing cloudy urine, difficulty urinating, or discomfort during urination. Make sure to drink plenty of fluids to reduce the risk of developing these symptoms
teeth may appear stained, but usually regain their normal appearance with brushing (this effect has been documented in children)
the tongue may become yellowish, brownish, or blackish and have a hairy appearance
excessive breakdown of red blood cells, causing a type of anaemia. Signs include: fatigue, headache, shortness of breath, dizziness, paleness, and yellowing of the skin and the white part of the eye
low white blood cell count
low count of cells involved in blood clotting
prolonged blood clotting time compared to normal. This effect may be noticed with nosebleeds or if you get a cut.

Frequency not known (frequency cannot be estimated from the available data):

inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
skin rash with blisters arranged in a ring with a central crust or resembling a string of pearls (linear IgA disease)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Amoxicillin Mylan Pharma

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the carton and blister after the letters "exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Amoxicillina Mylan Pharma contains
The active substance is amoxicillin.
Each dispersible tablet contains amoxicillin trihydrate equivalent to 1000 mg of amoxicillin.
The other components are: magnesium stearate, microcrystalline cellulose, crospovidone, strawberry flavour, aspartame.
Components of the strawberry flavour: maize maltodextrin, triethyl citrate (E1505), flavouring components, propylene glycol and benzyl alcohol.

Description of the appearance of Amoxicillina Mylan Pharma and contents of the pack
Amoxicillina Mylan Pharma 1000 mg dispersible tablets
The tablets are white or almost white, oblong in shape, measuring 22 mm by 10 mm, with a break line on both sides.
The tablets are packaged in PVC/TE/PVDC/aluminium blisters.
Amoxicillina Mylan Pharma 1000 mg dispersible tablets are available in packs of 12 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani 20, 20124 Milano
Italy
Manufacturer
HAUPT Pharma Latina S.r.L.
Strada Statale 156 Monti Lepini Km. 47,600
04100 Borgo S. Michele (Latina), Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands – Amoxicilline Centrient 1000 mg dispergeerbare tabletten
Italy – Amoxicillina Mylan Pharma 1000 mg compresse dispersibili

General recommendation on the use of antibiotics
Antibiotics are used to treat bacterial infections and have no effect against infections caused by viruses.
It may happen that a bacterial infection does not respond to a course of antibiotic therapy. Most often, this is due to the fact that the bacteria causing the infection are resistant to the administered antibiotic. This means that the bacteria are able to survive and multiply despite treatment.
There are several reasons why bacteria can become resistant to antibiotics. Correct use of antibiotics can help reduce the likelihood of bacteria developing resistance.
An antibiotic prescription is intended solely to treat the current illness. By following the recommendations below, you can help prevent the development of resistant bacteria, which could undermine the effectiveness of antibiotic therapy.

It is very important that antibiotics are taken at the correct dose, at the correct times, and for the prescribed number of days. It is important to read the instructions accompanying the medicine and, if they are difficult to understand, to ask your doctor or pharmacist for clarification.
Antibiotics should not be taken unless they have been specifically prescribed for you, and should only be used to treat the infection for which they were prescribed.
Do not take antibiotics prescribed for other people, even if the infection appears similar.
Do not give your prescribed antibiotics to other people.
If, after completing the treatment course as directed by your doctor, you have any unused antibiotic remaining, you must return it to a pharmacy for proper disposal.